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Randomized Controlled Trial of eScreen for Problematic Drug Use

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anne H Berman, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01532388
First received: October 27, 2011
Last updated: June 13, 2013
Last verified: June 2013
  Purpose

Objectives: This study compared the efficacy of eScreen in a two-armed randomized controlled design, measuring outcomes in terms of changes in problematic drug use up to one year after study recruitment. The eScreen brief Internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. Progress over time is shown in diagrams detailing consumption levels.

Method: Participants with only problematic drug use according to the Drug Use Disorders Identification Test (DUDIT),(DUDIT >0 for both men and women) or both problematic alcohol use according to the Alcohol Use Disorders Identification Test (AUDIT), (AUDIT >7 for men and AUDIT >5 for women) and drug use were randomized to T1 (n=101) or the control group (n=101). Outcomes on alcohol and/or drug use as well as health-related symptoms were assessed after 3, 6 and 12 months.

Hypotheses that were tested in this study are 1) that both groups would reduce their drug consumption and drug-related problems at follow-ups compared to the baseline level and 2) that participants in the eScreen group would reduce their drug consumption and drug-related problems to a higher extent than participants in the control group (no intervention) at follow-ups.


Condition Intervention Phase
Problematic AOD Use
Behavioral: eScreen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of eScreen for Problematic Drug Use

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Drug Use Disorders Identification Test-Consumption (DUDIT-C) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    The primary outcome measure for this trial was the change in total DUDIT score for the first four DUDIT questions, as a measure of drug consumption only, referred to as the DUDIT-C.


Secondary Outcome Measures:
  • Drug Use Disorders Identification Test (DUDIT) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
    Change in total DUDIT score, as a summarized measure of drug use (including drug consumption and drug-related problems).


Enrollment: 202
Study Start Date: September 2009
Study Completion Date: May 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: eScreen
Web based self-monitoring of problematic alcohol and drug use.
Behavioral: eScreen
Web based self-monitoring of problematic alcohol and drug use.
No Intervention: Control group
Untreated control group

Detailed Description:

Background: The aim of this study is to investigate the effects of an Internet-based screening and brief intervention (SBI) site for problematic alcohol and drug use among illicit drug users.

Method: Individuals searching for information about alcohol or drugs online who scored over 0 on the Drug Use Disorders Identification Test (DUDIT) and were 15 years or older were recruited for this trial and randomized into one group receiving Internet-based screening and brief intervention via eScreen.se(n = 101) or one assessment-only control group (n = 101). Both groups were screened at baseline and followed up at 3 and 6 months. The primary outcome measure was the DUDIT-C score and secondary outcome measures were DUDIT, AUDIT-C (Alcohol Use Disorders Identification Test-C) and AUDIT scores.Additional outcomes included the proportion of drug abstainers and those who made a clinically significant change in their alcohol and drug use. Four statistical models of analysis were used to conservatively assess results.

Results: A significant decrease in DUDIT-C scores at the 3-month follow-up occurred in both groups. Three out of four statistical models showed a larger decrease in the DUDIT score in the intervention group than in the control group (p = 0.006; p = 0.046; p = 0.001). Two models showed a continued decrease in AUDIT-Cand AUDIT scores also at the 6-month follow-up in the intervention group but not in the control group.No additional differences occurred.

Conclusions: The results are inconclusive but provide some evidence that SBI sites such as eScreen.se could be effective for short-term reductions of problematic substance use.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DUDIT >0

Exclusion Criteria:

  • DUDIT = 0
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01532388

Locations
Sweden
Karolinska institutet, Department of Clinical Neurosciene
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Anne H Berman, PhD Karolinska Institutet
  More Information